On February 22, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the European Medicines Agency (EMA) has accepted for review two new indication applications for its BTK inhibitor BRUKINSA (zanubrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with marginal zone lymphoma (MZL) (Press release, BeiGene, FEB 22, 2022, View Source [SID1234608794]).

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"As a BTK inhibitor designed to maximize BTK occupancy and minimize off-target binding, BRUKINSA demonstrated improvements in ORR and advantages in overall cardiac safety compared to ibrutinib in the ALPINE study in patients with relapsed or refractory CLL. Together with results from the SEQUOIA study in front-line CLL, BRUKINSA has the potential to become a preferred treatment option for patients with CLL and MZL in the European Union," commented Peter Hillmen, MBChB, Ph.D., Professor of Experimental Haematology at University of Leeds, and principal investigator of the ALPINE trial.

In November 2021, BRUKINSA received its first approval in the European Union (EU) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

"Following BRUKINSA’s recent EU approval in WM, we are pleased that BRUKINSA is now under review for two more indications—CLL and MZL. We are confident in the broad clinical evidence from its global clinical development program and hope to bring this next-generation BTK inhibitor to CLL and MZL patients in the EU," said Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene.

The application for in CLL is based on data included from two global Phase 3 trials of BRUKINSA in CLL—ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in relapsed or refractory (R/R) patients and SEQUOIA (NCT03336333) comparing BRUKINSA to bendamustine and rituximab in treatment-naïve (TN) patients. These two studies enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand and multiple countries in Europe.

Results from the ALPINE trial and the SEQUOIA trial were reported at the 26th European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2021) Virtual Congress in June 2021 and at the 63rd American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021, respectively.

The application for MZL is based on efficacy results from two single-arm clinical trials—MAGNOLIA (NCT03846427), a global pivotal Phase 2 trial in patients with R/R MZL who received at least one anti-CD20-based regimen, and BGB-3111-AU-003 (NCT02343120), a global Phase 1/2 trial. These two studies enrolled patients from a total of nine countries, including sites in the United States, China, Europe, Australia, and New Zealand. Results from the MAGNOLIA trial were reported at the 62nd ASH (Free ASH Whitepaper) Annual Meeting in December 2020.

Added Gerwin Winter, Senior Vice President, Head of Commercial, Europe at BeiGene, "We are proud of the progress BeiGene has made in Europe over the past year, with a growing team across the continent. The acceptance of our applications for MZL and CLL bring us a step closer to broadening access to patients."

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the Western countries, accounting for approximately one third of all leukemia cases.1,2 In 2020, an estimated 30,000 new CLL patients were diagnosed in Europe.2,3 CLL begins in cells that become certain white blood cells (lymphocytes) in the bone marrow but then go into the blood. Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.4,5,6 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.7 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.8

About Marginal Zone Lymphoma

Marginal Zone lymphoma (MZL) is a group of indolent non-Hodgkin’s lymphomas (NHL) that begin in the marginal zones of lymph tissue, representing approximately 5-15 percent of all NHL cases in the Western world.9 There are three different subtypes of MZL: extranodal marginal zone B-cell lymphoma or mucosa-associated lymphoid tissue (MALT) which is most common; nodal marginal zone B-cell lymphoma which develops in the lymph nodes and is rare; and splenic marginal zone B-cell lymphoma which develops in the spleen, bone marrow, or both and is the rarest form of the disease.10

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. In November 2021, the European Commission approved BRUKINSA for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On February 22, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies and AVEO Oncology (NASDAQ: AVEO) ("AVEO"), a commercial stage, oncology-focused biopharmaceutical company, reported that they have entered into a research collaboration to develop and study a first-in-class antibody radio-conjugate (ARC) targeting ErbB3, also known as HER3 (Press release, AVEO, FEB 22, 2022, View Source [SID1234608793]). Actinium will utilize its AWE technology platform and extensive radiotherapy know-how to conjugate one of AVEO’s ErbB3 targeted antibodies, with the potent alpha-emitting radioisotope Actinium-225 (Ac-225).

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"Actinium has amassed extensive clinical experience, technical know-how and research capabilities for the development of next-generation targeted radiotherapies that we are excited to bring to this collaboration with AVEO, which has a portfolio of high-affinity antibodies and is currently commercializing FOTIVDA (tivozanib) in advanced RCC. We believe ErbB3 is a validated and differentiated target that is aptly suited for radio-conjugate development. Using our AWE platform, we will harness the powerful Ac-225 payload to enhance targeted cell killing against a target that is overexpressed in a number of cancers that are difficult to treat with traditional oncology therapies. A member of the epidermal growth factor family of receptors, ErbB3 has been gaining increasing recognition as a validated targeted, we are committed to rapidly advance and evaluate this novel Ac-225 ErbB3 targeted radiotherapy together with AVEO," said Sandesh Seth, Chairman and CEO of Actinium.

"While we focus on the commercialization of FOTIVDA in advanced RCC,, we are pleased to announce this collaboration with Actinium in an effort to leverage our high-affinity antibody program to expand our robust portfolio with a potential first-in-class targeted radiotherapy ," said Michael Bailey, president and chief executive officer of AVEO. "We are excited to advance this ErbB3 targeted compound which is expressed in multiple solid tumors and is the third in the family of clinically validated ErbB targets."

Actinium’s AWE technology platform has created a Ac-225 CD38 targeting ARC using the blockbuster myeloma antibody daratumumab (Darzalex), in collaboration with EpicentRx for targeted radiotherapy CD47-SIRPα immunotherapy combinations and in collaboration with Astellas Pharma, to create theranostics for solid tumors. Actinium employs a multidisciplinary approach leveraging its team’s expertise and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug development to R&D and collaborations.

AVEO’s ErbB3 targeting antibodies are designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers and has demonstrated preclinical activity in multiple tumor models.

On February 22, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it has entered into a securities purchase agreement with an institutional investor, providing for the purchase and sale of 1,496,400 shares of common stock (or common stock equivalents) at a price of $2.80 per share, in a registered direct offering, resulting in total gross proceeds of approximately $4.2 million, before deducting the placement agent’s fees and other estimated offering expenses (Press release, Applied DNA Sciences, FEB 22, 2022, View Source [SID1234608792]). The Company has also agreed to issue to the investor unregistered warrants to purchase up to an aggregate of 1,496,400 shares of common stock in a concurrent private placement. The warrants will have an exercise price of $2.84 per share, be exercisable six months from the date of issuance and will expire five years from the initial exercise date.

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The offering is expected to close on or about February 24, 2022, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The shares of common stock (or common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) are being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On February 22, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the fourth quarter and full year of 2021 after the market close on Monday, March 14th, 2022 (Press release, Akoya Biosciences, FEB 22, 2022, View Source [SID1234608791]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call may do so by dialing (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 5291099. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

Akoya also announced that it will be virtually participating in the Cowen Annual Health Care Conference. Brian McKelligon, CEO, and Joe Driscoll, CFO, are scheduled to present on Tuesday, March 8th, 2022 at 9:50 a.m. ET. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On February 22, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and Vifor Pharma Group (Vifor Pharma), reported that the companies have amended and restated the terms of their license agreement, pursuant to which Akebia Therapeutics, Inc. (Akebia) granted Vifor Pharma an exclusive license to sell vadadustat, Akebia’s investigational oral therapeutic for the treatment of anemia due to chronic kidney disease (CKD), to Fresenius Medical Care North America and its affiliates (including Fresenius Kidney Care Group LLC) and other entities in the United States, subject to vadadustat’s approval by the U.S. Food and Drug Administration (FDA) (Press release, Akebia, FEB 22, 2022, View Source [SID1234608790]). Vadadustat’s Prescription Drug User Fee Act (PDUFA) date is March 29, 2022.

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The new agreement further supports Akebia’s commercialization strategy ahead of a potential first-in-class U.S. launch for vadadustat which, as previously noted, provides access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships. Previous agreements between the companies granted Vifor Pharma an exclusive license to sell vadadustat, if approved by the FDA, to Fresenius Kidney Care Group for use solely within its dialysis facilities and certain other third-party dialysis facilities in the U.S. The new agreement further expands this license to also include additional independent dialysis organizations.

"Vifor Pharma shares our commitment to bring innovative treatments to people living with kidney disease, which has been a cornerstone of our longstanding relationship," said John P. Butler, Chief Executive Officer of Akebia. "As we approach vadadustat’s PDUFA date and potential launch, we are thrilled to clarify the agreement, which we believe will enable our companies to get vadadustat to dialysis patients more quickly."

In consideration for the extension of Vifor Pharma’s customer group, Vifor Pharma agreed to an additional equity purchase of $20 million. Further, Vifor Pharma will contribute $40 million for use as working capital to partially fund Akebia’s costs of manufacturing vadadustat to support commercialization in the U.S. following FDA approval; such working capital to be refundable over time.

Under the terms of the amended and restated agreement, Vifor Pharma will accelerate payment of the previously agreed upon $25 million milestone to Akebia. Akebia will retain approximately 66% of the profit, net of certain pre-specified costs. Akebia will share the profit with Otsuka pursuant to the License and Collaboration Agreement between Akebia and Otsuka in the U.S.

Akebia has retained all rights to commercialize vadadustat, in collaboration with Otsuka, in the non-dialysis dependent market and to the remaining dialysis organizations representing approximately 40% of the U.S. dialysis market, following FDA approval.